Pulmonary drug delivery systems have been used for decades to deliver medicaments for the treatment of respiratory disorders. The principle behind pulmonary drug delivery is aerosolization of drug compounds to be delivered to bronchioles and alveoli. Despite facing challenges like particle size optimization and degradation, a number of companies have developed technologies to deliver treatments for diabetes, migraine, osteoporosis and cancer.
Many preclinical and clinical studies have demonstrated that pulmonary delivery of medicaments is an efficient method for the treatment of both respiratory and systemic diseases. The many advantages of pulmonary delivery are well recognized and include rapid onset, patient self-administration, reduced side-effects, ease of delivery by inhalation, and the elimination of needles.
It has been reported that in order to deliver a powder directly into the lower respiratory regions the powder should generally have a particle size of less than 5 (im. Further, powders in the 5-10 um range have been found not to penetrate as deeply and instead tend to stimulate the upper respiratory tract regions.
Despite the foregoing medicinal applications, methods for the delivery of nicotine, other than by traditional combustion alternatives, have not significantly deviated from delivery via the traditional transdermal and oral routes to include pulmonary delivery via inhalation.
Nicotine can be more easily acquired and stored as tobacco (or other plant material) than in a purified form (e.g. nicotine base) and the nicotine therein is preserved in a more stable form. Also, use of tobacco as a source of nicotine facilitates delivery of the natural flavors therein. Moreover, other alkaloids naturally present in tobacco, such as nornicotine, may be delivered along with the nicotine.
Combustion to release nicotine, however, produces a complex mix of additional compounds and particles in the form of smoke. Near combustion heat or high temperature conditions (greater than 150 degrees C.) to release nicotine from tobacco requires significant energy and a heat delivery system sufficient in strength to provide the high heat required. The nicotine derived from the tobacco at near combustion temperatures represents a relatively minor portion of that available upon combustion.
Thus, there is a need for new methods to prepare aerosols for nicotine delivery utilizing tobacco or other plant products. The present disclosure describes in part a method for combining such nicotine with a compound for forming particles comprising the nicotine and/or other alkaloid(s) for delivery in a gaseous stream to generate an aerosol for pulmonary delivery.